Senior Regulatory Lead, Advertising & Labeling

Kyverna Therapeutics; United States; Teletrabalho; USD 180 000 - 205 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Equity

Stock plan

Resumo da oferta

Kyverna Therapeutics is seeking a Senior Regulatory Leader to craft and execute regulatory strategy for product communications and core labeling. You will ensure US FDA, EMA, and global regulations are met across materials and labeling, including MLR reviews and health authority interactions.

Leading promotional review committees and directing labeling development, you will manage vendors and budgets, with travel ~20%.

Qualificações

• 8+ years of biopharmaceutical regulatory experience, including at least 6 years in advertising and promotion.
• Expertise in FDA promotional regulations, labeling, MLR review, and OPDP interactions.
• Strong leadership, communication, and project management skills; experience with Veeva PromoMats.

Responsabilidades

• Serve as regulatory lead for promotional and medical review committees, providing guidance on claims and fair balance.
• Direct development and maintenance of core, U.S., and patient labeling and lead health authority negotiations.
• Oversee vendors, budgets, and resources; travel approximately 20%.

Conhecimentos

Regulatory strategy

Leadership

Communication

Project management

Cross-functional collaboration

Formação académica

8+ years regulatory experience

Ferramentas

Veeva PromoMats

Descrição da oferta de emprego

Kyverna Therapeutics is seeking a Senior Regulatory Leader to craft and execute regulatory strategy for product communications and core labeling. You will ensure US FDA, EMA, and global regulations are met across materials and labeling, including MLR reviews and health authority interactions.

Leading promotional review committees and directing labeling development, you will manage vendors and budgets, with travel ~20%.